Medicine and Social Justice will have periodic postings of my comments on issues related to, well, Medicine, and Social Justice, and Medicine and Social Justice. It will also look at Health, Workforce, health systems, and some national and global priorities. Started 11/28/08. I hope you find it useful; if so, consider signing up as a "follower".

Wednesday, July 28, 2010

.The headline story in the June 28, 2010 issue of the Kansas City Star, by Dave Helling and Steve Kraske, is “Mailings turn aggressive”. It is about direct mail campaigns by those seeking elective office, how they have become a major part of the campaigning, and how the content is almost entirely negative – and sometimes hard to believe. For example, a state legislator running for Congress has a mailer attacking his primary opponent as a “Nancy Pelosi Democrat”, although the only obvious similarity this “staunch conservative” former legislator has with Ms. Pelosi is that they are both women.

The more interesting aspect is not the attack aspect of the ads, but that most of the non-attack “positive” campaigning, touting the candidates’ strengths and thus implicitly responding to attacks, is (among Republicans) to emphasize their negativity. Jerry Moran, a Republican congressman from Kansas’ “Big First” district is running against Todd Tiahrt, congressman from the 4th district (Wichita), for the Senate seat of Sam Brownback (who is odds-on favorite to be our next governor). Both have essentially the same, straight-down-the-Republican-line voting record, but Tiahrt has accused Moran of being less conservative. A recent Moran ad indicates that he fights for Kansas and then lists all the things he has opposed – which is essentially everything that the Obama administration has done. Moran is a nice, personable man and presumably has some good positive ideas, but apparently in the campaign it is not cost effective to promote them. (Note that the Tiahrt campaign takes the same tack, except when attacking Moran for not being conservative enough.) In the Republican primary proudly embracing charter membership in the “Party of NO” is apparently the name of the game, It is possible that in some parts of the country, candidates in the general election will feel pressure to say what they are for, but only if absolutely necessary. In Kansas, where the Republican nominee is pretty much guaranteed victory in most venues, it probably won’t.

In a recent article in Health Affairs, “The political challenges that may undermine health reform”[1], Theda Skocpol ties some of these trends to the future implementation of health reform. She accepts that there will be Republican gains, but also discusses the ways in which Democrats will likely respond, hoping to blunt those gains and prevent a complete Republican takeover of Congress. In its absence, she notes it is likely that most of the part’s of PPACA will be implemented, slowly and quietly, although some of the parts most likely to engage support (elimination of discrimination against those with pre-existing conditions on the individual market and allowing children to stay on their parents’ policies until 26) are front-loaded, going into effect this year. Among the most interesting things she says (to me, a non-political scientist), is that “Political scientists have long know that Americans are what is called ‘operational liberals’; they like specific government benefits. Yet these same Americans are also ideologically conservative, when arguments about government versus the free marked are posed in general rhetorical terms.”

Actually, this makes it almost sound like Americans are “operationally selfish”. Indeed there are many who are, like the family physician I knew in Texas who would mostly rant against the liberals in Washington and the need to elect more conservative Texans, until, in a cost-saving measure pushed through by those fiscal conservatives, the government delayed sending out Medicare payments to physicians. That was intolerable to him! Dr. Skocpol continues: “That is why we will see Republicans doing all they can to keep the argument at the systemic level through early 2012, when they hope to elect a president who will support repeal or make fundamental changes in the 2010 legislation.” No question that arguing against Big Government is going to win more votes than opposing Medicare, or Social Security. And few of the reliably conservative Republican farmers in Kansas (or elsewhere) are going to be won over by arguments against agricultural subsidies. In Missouri, which has more Democrats than Kansas but has a legislature controlled by Republicans, a statewide referendum is about to take place which would prohibit the federal government from forcing people to purchase health insurance. It is being sold with “freedom” arguments, and might well be unconstitutional, but it will be interesting to see how people vote. When turnout is light, the poor and uninsured are less likely to turn out than those who, like the bill’s legislative sponsors, already have insurance; in particular older voters, already receiving Big Government Socialized Medicine Medicare are likely to vote.

While there is much to criticize in PPACA (done very well by John Geyman, “Hijacked: Stolen health care reform V” in the Huffington Post), there is definitely some good. The insurance companies have backed off their threats to not cover people (or at least children) with pre-existing condition, suggesting that people will begin to see some real benefits. The real issue is seen in Dr. Skocpol’s final sentence, above; the Republicans are running on general conservative principles, but should they gain power they will implement a very anti-regular-people agenda, as was done under the Bush administration. This is not limited to health care; while “everyone” (me, for sure!) hates the bankers who brought on the financial crisis (see Maureen Dowd in the NY Times, July 28, 2010: “Washington gave the Wall Street banks billions, and, in return, they stabbed us in the back, handing out a fortune in bonuses to the grifters who almost wrecked our economy”), the Republican party leadership, far from punishing them or reining them in, has tried to block legislation that would even gently restrict their most outrageous activities.

If we are lucky, maybe voters in Missouri and in other places will show that “operational liberals” who “like specific government benefits” are not all like that Texas doctor, and will also support specific benefits that help others. We have seen many polls showing that a majority of Americans favor universal health care even for all, so the sense of common purpose is not dead. Maybe they won’t, but we can hope.

Thursday, July 22, 2010

.Now that the health reform law, PPACA, has passed into law, and while we wait for the years to pass that will usher in many of the changes, as well as the regulations that will actually guide how those laws will be implemented, policy people and pundits have resumed publishing articles about what other things should be / need to be done. Most of these were suggestions that had been made previously and are either being advanced because PPACA has included funding for them and the authors want to emphasize how beneficial they will be, and others are ideas for health improvement that may not specifically be in the law but that the authors feel are still important and should be advocated for. In addition, of course, there are the “flames” and attacks on “Obamacare” as “socialized medicine” (which it isn’t close to, unfortunately in many people’s opinions, including mine).

In the first group I would include articles that address Community Health Centers (CHCs), or more specifically Federally-Qualified Health Centers (FQHCs), the patient center medical home (PCMH), and increased primary care, for all of which there is enormous funding in the new law. “Health reform and primary care – the growing importance of the community health center” by EY Adashi, HJ Geiger, and MD Fine (NEJM, 3Jun2010;362(22):2047-10) addresses all 3. Dr. Geiger was central to the creation of the first two CHCs, Columbia Point in Boston and Mound Bayou, Mississippi, in 1965. The article talks about how CHCs are built on primary care and on the principles of the patient-centered medical home (before those principles were articulated under that name), and calls for expansion of CHCs as a key vehicle for caring for all Americans, not only the “underserved” and the use of CHCs as venues for demonstration projects for PCMHs. It also includes an excellent map showing the percent of people in each state currently served by CHCs (West Virginia is tops with over 15%), and another with dots showing the location of all of them (very dense over WV).

Other articles on these topics include JF Markuns, B Fraser, and JD Orlander on developing the skills needed for medical directors in CHCs, “The path to physician leadership in community health centers: implications for training”, (Family Medicine Jun2010;42(6):403-7). This is important because a poor relationship between physician and non-physician administrators, often born of unshared assumptions about who is responsible for what, has frequently been a major stressor in many CHCs. Other pieces look at the medical home in particular populations -- “Health care reform and the opportunity to implement a family-centered medical home for children” (D Laraque and CCJ Sia, JAMA 16Jun2010;303(23)2407-8)* and in educational settings – “Medical student exposure to components of the patient-centered medical home during required ambulatory clerkship rotations: implications for education” (JW Saultz, et. al, Acad Med Jun2010;85(6):965-73)*.

The second group of articles address issues that the authors feel remain to be dealt with. A major one is quality of care, obviously of great concern to everyone who receives (and provides) health care. Harold Sox and Sheldon Greenfield, in “Quality of care – how good is good enough?”* (JAMA 16Jun2010;303(2):2403-4) argue that setting threshold values for adherence to practice measures is not a very good way to measure quality as patient characteristics, individually and in populations cared for by different physicians, groups, and hospitals as well as in different regions, differ greatly. They suggest measures of the quality of the decisions made by physicians, and the degree to which they are based on the best evidence in the context of the actual patient. Marco D. Huesch, in “Payment policy based on measurement of health care spending and outcomes” (JAMA 2010 Jun 16;303(23):2405-6)*, further addresses the flaws of many of the assumptions on which “pay for performance” programs pay. In the measurement of quality, we have to be especially careful of the pitfalls of “streetlight research”(see my post of Feb 26, 2009, Defining "Streetlight" Research) and measure what we find easiest to measure, whether or not it is what we really want to know about.

In an area getting, in my opinion, much closer to the edge of a bad idea, Robert Brook, of the RAND Corporation writes in of “Rights and responsibilities in health care: striking a balance” (JAMA 9Jun2010;303(22):2289-90)*. He makes comparisons to car warranties, which are often invalid if the owner has not followed the prescribed maintenance schedule. All of us would agree that it would be better (mainly for their health, I hope, but also for the bottom line) if everyone would adopt only the best health behaviors; indeed, we might argue that individual responsibility is critical. Of course, such arguments are inherently classist (on a group, not individual basis, as in all population issues) and are usually made by those who have the resources (financial, educational, “values”) to be more likely to be able to adopt such behaviors (and we don’t all do it – there are actually white, prosperous people who are overweight, drink, use drugs, smoke, don’t exercise enough, etc.) He calls for “classes” in the workplace using “sophisticated adult learning materials” to educate people. Beyond the fact that this would leave out those who don’t have a workplace, or work in a business too small to afford such class, this construct misses the fact that the reason people do not adopt such behaviors has very little to do with their not knowing that they are good ideas, and very much to do with the other parts of their lives that make adopting such behaviors very difficult. Most important, people are not cars, and refusing to honor a warranty is not the same as refusing to cover health care costs; we are not (and should not) going to allow people to die in the streets because they didn’t behave well and don’t have the money to bail themselves out of these poor decisions by paying for their care out of pocket.

The real problem is that all of these ideas, whether good (CHCs, primary care, the PCMH, emphasis on quality) or not is that under the new PPACA law, as before it, not everyone has adequate access to health care. Our reimbursement systems continue to reward providers (physicians, hospitals, health plans, and the drug and device manufacturers who sell to them) for doing more, using more technology, doing more procedures – for those who (or, mainly, whose insurance) can pay. And many people are still not covered. Medicaid will be expanded (for a while) but not yet, and will only pay (for 2 years) Medicare rates (and even this is rejected by many providers). Undocumented people will not be covered at all, although they will be here and get sick and need care. CHCs are neat, but as I have noted before, they have an incentive to locate where there are lots of Medicare and Medicaid patients, for whom they receive cost-plus reimbursement, not where there are uninsured and undocumented people. We need more primary care providers, we probably would benefit from true medical homes, and for goodness sake we need better quality, but without a health system that is actually universal, covers everyone, and has systematic means of cost-control, they are relatively less important, the cart before the horse, whistling past the graveyard. Even quality.

In 1994, Schiff, Bindman, and Brennan wrote “There is a profound and inseparable relationship between access and quality: universal insurance coverage is a prerequisite for quality care. Because quality must be population based, traditional definitions of quality should be broadened to include the gravest of quality deficits—denial of care. The most important prerequisite for access is health insurance.” (“A Better-Quality Alternative Single-Payer National Health System Reform”, JAMA 14Sep1994;272(10):803-80).

Denial of care and lack of access are still the greatest quality deficit. Discussions of quality that include only those “inside the tent” and ignore all others are specious and offensive; all discussions of quality must start from “everyone needs access”.

*Hyperlinks are not provided to these articles as they are not available free on line.

Friday, July 16, 2010

.On Wednesday (July 14, 2010), the FDA advisory council looking at whether to ban rosiglitazone (Avandia ®), a drug for the treatment of diabetes that has been found to significantly increase the rate of heart attacks (MIs) decided to not ban it, but to place significant restrictions on its use. On the NPR story Thursday (July 15, 2010), a panel member who is a consumer said (and I paraphrase, but this is close)“We were very concerned about it but it is effective for lowering blood sugar, which for we diabetics is the Holy Grail.”

What concerns me is that a very well-informed (at least by virtue of being on this panel) consumer (and, from the comment, presumably a person with diabetes) would refer to lowering blood sugar as “The Holy Grail”. As I have noted in several recent posts (most recently Statins and scientific integrity, July 6, 2010), the only patient-important outcomes are premature death and quality of life (morbidity); the only reason any intermediate, or “surrogate”, variable (e.g., blood sugar or Hemoglobin A1c [HbA1c – a longer-term measure of blood sugar], blood pressure, cholesterol level, etc.) is the degree to which it is linked to one of the two patient-important outcomes (mortality or morbidity); none is in itself a patient important outcome, not to mention a “Holy Grail”. Who cares what one’s blood sugar (or cholesterol or blood pressure) is unless we know that it is likely to lead to a bad outcome? It is the outcome that is important. (again, see GY Gandhi, et. al., “Patient-important outcomes in registered diabetes trials”, JAMA. 2008 Jun 4;299(21):2543-9).

In the case of diabetes and blood sugar, there is good evidence that lower blood sugar significantly reduces the rate of cataracts in the eyes, which is certainly a morbidity. There is some evidence that it may be linked to lower rates of microvascular disease (such as kidney and retinal conditions) which definitely cause morbidity. Much weaker evidence relates it to death. Indeed, in a recent publication from the ACCORD trial[1], “tight” control of diabetes (getting the HbA1c below 6, rather than 7) did not decrease microvascular morbidity and led to increased mortality.

We also know that the major cause of death for people with diabetes is macrovascular disease, primarily heart attack. Thus, a drug which increases the rate of heart attacks (definitely increasing morbidity and probably mortality) even if it decreases blood sugar (a surrogate variable) is of great concern.

The actual decision (if the FDA itself chooses to follow the panel’s recommendation and not ban rosiglitazone) to balance the increased risk of heart attack with the benefit of reduced blood sugar, will rest with the patient and the physician. However, responsible physicians – and certainly the leading diabetes experts who are on this panel – need to move away from emphasizing surrogate variables, like blood sugar and HbA1c, to such a degree that patients lose sight of the real outcomes they want to try to achieve..[1] Ismail-Beigi F et al. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: An analysis of the ACCORD randomised trial. Lancet 2010 Jun 29, 1-12.

The authors used two surveys administered annually by the Association of American Medical Colleges (AAMC) to medical students: the Matriculating Student Questionnaire (MSQ) given when students begin school and the Graduation Questionnaire (GQ) given at graduation. They were able to match the questionnaires of nearly 2/3 (64.9%) of medical students graduating in the 10 years 1997-2006 to look at the degree to which the answers students gave to questions on the MSQ and GQ would predict their choice of specialty. It takes a while to get through the description of how they grouped questions, and “weighted factors”, but there are a number of important findings. Most of them not surprising, but this study provides additional data support for things we have been seeing.

Fewer graduates are entering primary care. For some reason the AAMC’s GQ counts 6 “primary care” areas, including, in addition to the usual family medicine, general internal medicine, and general pediatrics, also obstetrics/gynecology, internal medicine subspecialities (IMSS), and pediatric subspecialties (PdSS). However, this study separates them out. The percent of students entering the first 4 of these dropped from 1997 to 2006 (GIM from 15.7% to 6.7%, GP from 10.2% to 6.6%, FM from 17.6% to 6.9%, and OBG from 8.2% to 6.1%), while the subsubspecialties increased (IM from 6.8% to 11.4%, Peds from 2.2% to 4.4%). This increase in the last 2, however, did not compensate for the decrease in the first 4 so there was a net decrease from 60.7% to 42.1% for all these “primary care” specialties. The increase was in, then, surgical specialties, and more significantly in specialties such as radiology, anesthesiology, and emergency medicine. And the trend continues – although not part of the study, the article reports that the total % of students entering these 6 specialty areas in 2008 was down to 30.3% from the 42.1% in 2006. Remember, this is not just real primary care – it includes medical and pediatric subspecialties!

The more important part of this article is its correlation of certain demographic and attitudinal characteristics with specialty choice. Being female is important: over the 10 years of the study 45.1% of graduates were women, but they were over-represented in each of the 6 fields except IM subspecialties: 77.3% of OBG, 72.6% of GP, 58.2% of PdSS, 50.8% of FM and 49% of GIM. Indeed, the authors suggest that one of the reasons for the continued downturn in entry of medical students into PC fields is that the % of women in medical school, which was increasing during the study period, tended to compensate somewhat for the decreased interest in PC among men. Now that the % of women in medical school has stabilized, at roughly 50%, while interest in PC continues to go down, this is no longer having the same compensatory effect.

Compared to white students, underrepresented minority (URM) students were somewhat less likely to choose the PC specialties of GIM, GP, and FM, while Asian/Pacific Islander (As/PI) grads were less likely to choose FM, OBG, GP and PdSS, according to the text, but there are subtleties to this. For example, white students were 68% of the total but 75.3% of those entering FM; however, the % of URM students in FM (14%) was also greater than in the overall cohort (12.7%). The difference is that As/PI were much lower in FM, 9.9% compared to 18.2% of the overall cohort. In this report URM students include black, Hispanic, and American Indian/Alaskan natives, while the As/PI group includes some groups that are truly underrepresented in medicine and are usually counted by Federal grantmakers as URM, as well as some groups, e.g., South Asian, Japanese, Chinese, that are in fact over-represented in medicine. Many of these are among the 15.7% of students who had one or more parents who was a physician or the 24.1% more who had a non-physician professional parent. This is important because “…a student’s having a physician parent had a pervasive negative effect on graduates’ choice of any generalist-primary care specialty…” while those with non-physician professionals as parents were more likely to choose GIM, GP, and IMSS.

Though highly-touted as a deterrent to entering PC (and, perhaps, of more significance now than in the early part of this study period) debt had only a “modest” effect; students with higher debt were less likely to choose GP, PdSS, GIM, or IMSS, but more likely to choose OBG, and choice of FM was essentially unaffected. The probability of students from public medical schools entering PC was much greater than from private schools, a consistent finding of all studies, presumably reflecting the curriculum and emphasis of those schools as well as the characteristics of the students they select. The authors linked a number of questions to assess students’ “choice of medicine as a career goal” (including the importance of innovation and research, social responsibility, and prestige), and students’ “perceptions about medicine and medical practice” (including altruistic beliefs and the belief that the demands of medicine interfere with family/other interests). All were high, and few led to big differences in specialty choice. Among the most significant of those that did were “intention to practice in an underserved community” (more PC, especially FM), and “interest in academic faculty positions” (very low FM -- the odds of being interested in academic practice compared to full-time non-university practice was only 12% for someone entering FM, compared to GIM’s 86%, IMSS’ 185% and PdSS’ 316%!).

So what does all this tell us that is new? Not much. There is a dramatic decrease in the number and percent of students entering true primary care specialties, combined with some increase in the number entering obstetrics/gynecology, internal medicine and pediatric subspecialties and a large increase in specialties that are in no way primary care. It tells us that students who are interested in and attracted to, and are wooed by, “high-status” research and specialty care medical schools are less likely to enter primary care; that being the child of a physician or having a high family income makes one less likely to enter primary care; that students interested in caring for the underserved and women are more likely to enter primary care (although not rural practice). So what does this mean “we” should do?

Well, that depends on who “we” are. If “we” are the selective, high-status medical schools who are low on social mission (see A New Way of Ranking Medical Schools: Social Mission, June 20, 2010) and “we” value what “we” do, maybe “we” shouldn’t do anything. The same might be said if “we” are the schools that tend to be high on social mission and production of PC physicians. If, however, “we” are the American people, who need more primary care and rural physicians, or the politicians and policy makers who actually can have some influence, “we” need to make policies that reward schools that select the students whose demographic and attitudinal characteristics make them more likely to enter primary care, underserved, and rural practice. And those schools whose curriculum (formal and informal) and faculty attitudes and relative status-within-the-institution favors those same outcomes. And pay, on the back end, more money to those who do what “we” don’t have enough of (primary care, underserved and rural practice) than those who do what “we” have too much of already.

Whether or not “doing the same thing over and over again and expecting different results is the definition of insanity”, it is sure not going to accomplish any change in the physician workforce..

Tuesday, July 6, 2010

.“Statins” are a class of drugs that lower lipid levels, especially low-density lipoproteins (LDL, “bad” cholesterol), and raise high-density lipoproteins (HDL, “good” cholesterol). Since we know elevated LDL levels are associated with higher risk for a number of vascular diseases, mainly coronary heart disease but also stroke, it made sense that these drugs would be beneficial for preventing recurrences in people who had prior heart attacks and strokes (“secondary prevention”) as well as preventing a first attack in those who had the risk factor of elevated LDL (“primary prevention”). Indeed, studies have shown the former; that is, that the use of statins reduced the risk of both a second attack and dying. However, most of the studies that have been done, and showed benefit, studied both groups, people who had already had a coronary event and those with elevated LDL who had not, and combined the results. The first big study that presumed to show benefit of these drugs for primary prevention was the JUPITER study (“Justification for the Use of Statins in Primary Prevention” – all these studies have cute, if often tortured, eponyms). It specifically looked at the drug rosuvastatin, marked as Crestor ® by its manufacturer, AstraZeneca, who also happened to fund the JUPITER trial.

Two articles that just appeared in the Archives of Internal Medicine (V 170, #2, June 28, 2010) raise serious questions about the use of statins for primary prevention. But they also raise serious questions about research ethics, particularly when trials are industry funded, and the strategic manipulation (not falsification) of the data that is presented to make drug therapy look better – this can mean billions of dollars in sales for the manufacturer. They also point out the danger of looking at intermediate, or “surrogate”, outcomes (in this case, lowered cholesterol and LDL) rather than the ones of real interest to patients, which are, essentially, death (mortality) and the quality of life (morbidity). I have discussed this previously (“Quality and Chronic Disease Management,” Feb 24, 2009, and “Physician conflict of interest” Dec 8, 2008; see also the article by GY Gandhi, et. al., “Patient-important outcomes in registered diabetes trials”, JAMA. 2008 Jun 4;299(21):2543-9.)

The first article, “Statins and all-cause mortality in high-risk primary prevention”, by KK Ray, et. al. (Arch Int Med, 28 Jun 2010; 170(12):1024-31) is a “meta-analysis”. This is a type of study that looks at a group of previously-done studies to try to determine if there is a consistent conclusion that is stronger because it includes more patients than any one study, or weaker because the various studies contradict each other. The authors’ goal was to tease out the results for primary prevention from studies that had looked at the use of statins for both primary and secondary prevention. There were 11 studies that met their criteria, which had a total of 65,229 (= “a lot”) of participants. Their Conclusion (verbatim from the abstract): “This literature-based meta-analysis did not find evidence for the benefit of statin therapy on all-cause mortality in a high-risk primary prevention set-up.” This is not to say that the statins did not lower LDL; they did, and significantly, but in the population of people that had not yet had a coronary event or stroke, they did not prevent mortality. It is important to note that they did also, to a small degree, decrease the risk of having a heart attack, although not of dying. The reduction in risk was about 1.5%; that is, if 200 people are treated for 5 years, 3 will not have heart attacks (NNT=67 over 5 years). The previous studies, by mixing up those who did have a prior event and did have lower mortality (secondary prevention), with those who had not, showed, on net, a benefit. This study demonstrates that there is no reduction in mortality from using statins as primary prevention; whether the small reduction in MIs and their associated morbidity and cost is worth the administration of statins in high-risk patients is at least questionable, and may be an issue for each patient to decide with their doctor.

What about the JUPITER trial? This is the subject of the second article, “Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy”, by M deLorgeril et.al. (Arch Int Med 28 Jun 2010;170(12):1032-36. In a scathing “critical reappraisal” the authors note a slew of flaws in both the conduct and reporting of the JUPITER study. These include ending the study early, after only 2 years, at a time when it appeared that there was mortality benefit from the patients treated with rosuvastatin but when the curves were beginning to come together (i.e., maybe with more time the apparent benefit to rosuvastatin treatment would have disappeared and there would have turned out to be no difference in mortality rate), publishing reports in which the end of that curve was truncated, to not show the coming together, and publishing “subgroup” analyses that seemed to show benefit (by gender) but not where they didn’t (patients with diabetes). Most surprisingly, JUPITER had what seemed to be an extraordinarily low rate of fatality from myocardial infarction. The authors note that, to be able to get meaningful data to look at, they had to do calculations from the data presented by the JUPITER authors. For example, to know how many people died from heart attacks (myocardial infarction, MI) they had to subtract “nonfatal myocardial infarction” from “any myocardial infarction. This is not falsification, but it is very unusual for authors to present the data in a way that readers are required to make such calculations in order to get very important information. The rate of fatal to non-fatal MI was extremely low compared to studies from the World Health Organization, that show it to be 40-50%; in JUPITER it was 8.8% in the placebo group and 29% in the rosuvastatin group. First of all, it seems, if this data is correct, the fatal to non-fatal MI rate was 3 times as high in the group treated with rosuvastatin as in the group that was not treated (surely not the a point the authors and sponsoring company wanted to emphasize). Moreover, everyone in the study was “…unexpectedly – and inexplicably – highly resistant to acute ischemia and infarction.” The authors of this article suggest that there are many inconsistencies and implausabilities in the JUPITER data.

They then go on to discuss at length the roles of the sponsor (the drug company) and conflict of interest in reporting the data both by the sponsor and the principal investigator, who is co-holder of a patent for a test that is used to show “risk” for coronary artery disease (called “C-reactive protein, or CRP). They refer to other industry-sponsored flawed studies, including those about rofecoxib (Vioxx ®) and gabapentin (Neurontin ®), which I have discussed previously (“The ‘Neurontin Legacy’”, Jan 22, 2009). A superb editorial by Lee Green, “Cholesterol-lowering therapy for primary prevention: still much we don’t know” (Arch Int Med 28 Jun 2010; 170(12):1007-8) summarizes these issues.

Think about this. We have a bunch of studies that seem to show that statins are effective for prevention of cardiovascular events (heart attack and stroke) and prevent death. Turns out that they do this for those who have already had a heart attack, but for those who haven’t, the reduction in heart attack is small and there is no reduction in mortality. The use of statins in the much larger group, people with elevated cholesterol who have not yet had a heart attack, means big money for the drugs’ manufacturers. Studies that mixed the two groups blurred the distinction.

Then we have a big study (JUPITER) that purports to show that statins ARE effective for primary prevention, but that study is funded by the drug company and is seriously flawed. We know elevated cholesterol is associated with heart attack and we presume lowering cholesterol would help prevent those heart attacks, but, amazing and very important, when the study is actually done, the data doesn’t show it. (In studies looking at another such indicator, homocysteine, it was shown that, while elevated homocysteine levels are associated with heart attack, and folate – a cheap drug – lowers homocysteine levels, this did not decrease the rate of MIs. Too bad for the makers of the expensive homocysteine level test.)

I assume that I do not have to review the conflict of interest in the study being funded by the drug company and having the principal investigator a patent holder of a test that is highly used for assessing MI risk. The obvious concern is not that this was a potential conflict in the JUPITER study, but that it in fact led to selective interpretation and presentation of data (and the answers to how they had such a low rate of fatal MIs is still not in). This certainly challenges the claim we sometimes hear that just because there is a potential conflict of interest, it doesn’t mean that there is bad science being done. Of course, intrinsically it doesn’t, but this is one more example – with Vioxx and Neurontin and others – to show that it often does. And it also makes it harder for those who would argue that accepting industry gifts (whether lunch or fancy vacations) is benign. All these issues make a great example for teaching students, about conflict of interest, surrogate measures, scientific integrity, and how, from big issues to small ones, self interest colors our perceptions (see J Dana and G Lowenstein, “A Social Science Perspective on Gifts to Physicians From Industry”,JAMA. 2003;290:252-255)..

Thursday, July 1, 2010

This "Guest Post" is from David Wachsmuth, who was arrested at the G20 event in Toronto. I wanted to share it, and didn't know how else, as it is too long for "Facebook".

Arrested at the G20This weekend I was in Toronto demonstrating against the meeting of the G20 that was taking place there. At 2:45 AM on Saturday night I was arrested for a ‘breach of the peace’. The nineteen hours that followed were probably the most infuriating, frustrating, frightening ones of my life. Unfortunately, from what I now know, my experience was very similar to that of many of the over 1000 people who were arrested over the weekend. So what I'm about to describe, despite being intensely personal, probably speaks for many of us, at least in part.In preparation for the huge number of arrests they presumably planned on carrying out, the police had set up an ad hoc detention centre at an old film studio in the east end of Toronto. On Saturday night, I went with one of my best friends—who was a legal observer at the demonstrations—to the detention centre to join a midnight jail solidarity action in support of those who had been picked up earlier in a violent and arbitrary series of beatings and arrests, including of many people not demonstrating at all but simply in the wrong place at the wrong time. After a few hours of peaceful and spirited demonstration (featuring an excellent marching band), the police ordered us to disperse shortly before 2:00 AM. Like everything else this weekend, that was accomplished by surrounding us on all sides in enormous numbers of cops in full riot gear. (I filmed some video of the demonstration and the arrival of the police, which I have uploaded at http://bit.ly/aEiNaV.) The 150 of us were outnumbered at least two to one. There was some discussion of staying despite the order to disperse, but that only lasted a minute or so, and shortly everyone was filing between the ranks of riot police in the direction we had been ordered to go. A few minutes after we started leaving, and with no warning whatsoever, riot cops cut through the column of protesters and sealed off the two dozen of us at the back. We asked to be allowed to leave as they had just told us we were instructed to do, but we were instead told that we had had our chance to leave and had failed to take it (an odd idea, since we were walking away when they sealed us in). We were all arrested.The arrest itself took about 40 minutes and was uneventful. The only notable thing was how uncomfortable and difficult it is to hold your hands on your head for that amount of time. Since I was nearly the last person to get handcuffed, I had a lot of time for this to sink in. It is much more uncomfortable having your hands handcuffed behind your back, which is what happened next, but I expected that. The cop who dealt with me took me to the edge of where all the arrests were being made, asked me various questions, searched me, and so on. After a minute or two, I realized there was quite a lot of light on me, and it turned out that I was being processed right in front of a television camera, with a reporter making a report. So I asked to be moved to somewhere a little less obtrusive, but the reporter apparently got the footage she was looking for, since various people (including my mother) subsequently told me that they saw me on the news. This had at least the positive effect of letting my loved ones know what happened to me, since I was not allowed a phone call in the 19 hours during which I was detained. My arrest papers say I was arrested at 2:49 AM.We were slowly loaded into paddy wagons to be taken to the detention centre. After various delays, we were stuffed into little miniature jails inside the vans (in my van there were four cells, each of which held two of us) and off we went. We spent the next 30 minutes or so sitting in these tiny little van-jails. Sitting, because the drive was only a minute or so to the detention centre (we had been protesting outside of it). The rest of the time we were parked in what sounded (we couldn't see anything out the tiny little grated windows) like a big room with a lot of prisoners in it. The highlight of this time was the spontaneous round of mass meowing that came from the prisoners outside; the cages we were in really did feel like animal pens. The lowlight was my increasingly aching left arm from being held awkwardly behind my back in the handcuffs (the plastic cable-tie kind, incidentally, not the real metal deal).We were unloaded from the paddy wagons into a set of gender-segregated cages. In the end I spent time in three separate ones, although they were all the same. They were twenty feet by ten feet, with a four-by-four-foot washroom inside. The washrooms had no door, and no toilet paper (some previous inhabitant had stashed a little in our first cage, but it was quickly used up). There were generally 25 or 26 people in my cage, which comes out to just over seven square feet of space each. For the entire time we were imprisoned, we had to rotate between standing, sitting and lying down, since there wasn’t nearly enough room for all of us to do either of the latter two at the same time. Lying down wasn’t a means to actually sleep; at least in my case the combination of the cold temperatures and bright lights (plus the steady ruckus) ruled that out.I don’t know how to describe the way we were treated in those cages except as blatant and probably illegal harassment and violation of our basic rights and freedoms. The list is fairly long. None of us was ever given the opportunity to make a phone call or speak with a lawyer, despite having told that we had the right to do so upon being arrested. Some people (not including myself) were never even read their rights in the first place or informed of their charges. We were kept in handcuffs throughout the day. In the entire time I was incarcerated we were given two tiny little ‘sandwiches’—a single slice of soy cheese and a bit of margarine on a dinner roll. I believe we were given four small styrofoam cups of water, although it may have been five. One of us was a minor, who was never allowed to contact his parents. Two people had serious medical problems that received pathetically insufficient attention. It took us something like 40 minutes to get a medic when one of them was bleeding from under his fingernails and on the verge of collapsing. The guards alternatively taunted us, threatened us, lied to us, or ignored us. Once, when we had been calling for food for some time, a guard deliberately sat down in front of our cell and ate his lunch.And it was not as if we were a bunch of hardened criminals. Of course, even if we had been, the guards’ behaviour would have been completely inexcusable, but in fact not a single one of us had been arrested for anything that resembled just cause. A little under half of the people in my cages had been at the same demonstration as me. About the same number had been arrested en masse outside the Novatel hotel; they were surrounded on all sides by police while engaged in a peaceful demonstration, and then beaten and taken into custody. The rest of the people I met were random passersby. The most egregious was a TTC employee in full uniform, who was jumped by riot cops as he was arriving at his shift. I later found out that he spent 36 hours in custody with no phone call, lawyer, or charges, which I understand to be unequivocally illegal (http://bit.ly/aIXnUG). A few people were arrested for the hitherto unknown crime of dressing in black and going to punk rock shows. One of these was in from out of town, and didn’t even know what the G20 was. Two women we talked to cage-to-cage were trampled by cops on horseback (one, who looked like she was in her 60s, got a broken arm), and were being charged with obstruction of police.It would take far too long to describe all the various forms of harassment we were subjected to, but the major theme was fear and uncertainty. The guards took people from one cage and put them in another, keeping them disoriented and preventing them from getting to know their cage-mates, and keeping the rest of us uncertain about whether they had been released or just shuffled. The police told us on a number of occasions that we were about to be released, only to immediately ignore us for hours and hours. We were repeatedly asked to identify ourselves—twice guards took an inventory of everyone’s name and ID number, and tried to do so a third time—but we were also repeatedly asked if so-and-so was in our cage. He almost never was.While I was in the detention centre, I was inclined to chalk these things up to incompetence and confusion on behalf of the police. Almost 900 people were arrested, and the centre was clearly swamped. But after getting out, talking to others who were imprisoned, and thinking more about it, I now find it hard to escape the conclusion that this confusion and uncertainty was deliberate. We were told too many times to count that the guards were working as fast as they could to process us, but that the paperwork was taking a long time. But when they actually released us, the paperwork they had told us we would need to participate in never happened. They just walked us 50 feet to the exit and handed us our possessions. After talking with a number of people who were arrested, it seems clear that many or most people in my situation were held for 18 to 23 hours—just under the legal maximum—and that therefore the endless promises of impending release were deliberate lies.The result of all this was that we were constantly on edge. We were alternately furious, frightened, depressed, manic, and inert. At some points we were all banging on the cage and screaming at the top of our lungs. At other points we brooded silently. One of us went into shock. By the time we were released, the random passersby were sounding just as radical as the protesters. We had been arrested for different reasons, but the appalling treatment we received was the same, and united us in our outrage.Why did this happen? At the largest scale, it seems clear that the police made extended preparations for mass arrests and an intimidation campaign against people exercising their democratic rights to protest. This is a key component of the ‘Miami Model’ of protest disruption and repression that Toronto police followed so strictly (http://bit.ly/al8eaR). Earlier in the day, the police had strategically abandoned the streets to a group of 'black bloc' protesters, and left a few empty police cars in the middle of the road. This point should be emphasized: there were thousands of police on the streets throughout the entire weekend, but, somehow, when a small group of protesters decided to break off from the main rally and ‘go rogue’, the police simply melted away. The Sun has now reported that this was an explicit order from police central command: http://bit.ly/cnAqIv. The resulting hour or two of smashed windows and burned cars happened with more or less no police presence whatsoever, despite the fact that it happened on the busiest streets in the downtown. The cops didn’t lose track of the protesters; police helicopters were filming the black bloc from above (and passing on the footage to the media). It would have been the easiest thing in the world to simply surround the one or two hundred black bloc protesters with five or six hundred cops and arrest them, if that had been what the police had wanted to do. Instead, the cops left them completely undisturbed until they had smashed their way from King and Bay all the way up Yonge St. to College and then back to Queen’s Park (passing by police headquarters, even!), where they changed out of their black clothing.I can’t figure out an explanation for this other than that the police deliberately encouraged property destruction as a pretext for subsequent repression. The black bloc obliged, and after the cruisers were set on fire and a bunch of storefront windows were smashed, the cops announced that their tactics would have to change in response to this property destruction, and began a violent and arbitrary series of beatings and arrests, including of many people not demonstrating at all but simply in the wrong place at the wrong time.This was the context for all the arrests that filled the cages of the detention centre, and the harassment and intimidation that police inflicted inside the cages is an exact counterpart to the violence that they inflicted outside. At a smaller scale, many of the individual guards chose to taunt, harass, and abuse us, when they could have chosen not to. I’m sure many thought that we deserved it, and others who didn’t found it easier to just let it happen. The abuse was worse because it was completely arbitrary. Sometimes if we asked for a medic, guards would show up quickly and our ill cage-mate would be taken to a medic. Sometimes guards would show up quickly but do nothing. Sometimes guards would not show up at all. This is the same arbitrariness that terrorized the peaceful protests at Queens Park and elsewhere, where riot cops made ‘dash and grab’ arrests—rushing quickly at a single protester (or passerby) with no warning, beating her, and taking her into custody. It is one of the most disturbing features of all the police violence that occurred over the weekend, because it defies logic and accountability.I’m acutely aware of how lucky I was relative to so many of the other innocent people who were arrested over the weekend. For one, I wasn’t physically abused prior to being taken into custody. But more than that, I’m an educated, well-off, straight white male. I’m sure it’s not a coincidence that the person in my cage held the longest was an indigenous man. And we now know that queer people were segregated into separate cages; women were threatened with rape and subjected to invasive strip searches (http://bit.ly/9Qlxfb).I’m now back in New York City, where I live, so I haven’t been able to participate directly in the growing collective efforts to seek justice for all the injustice that occurred in Toronto over the weekend. I wish I could. Being on the business end of police brutality hasn’t changed my politics at all; it’s confirmed them, and made me angrier. At the same time, while I am optimistic that forthcoming investigations and inquiries will condemn a certain amount of the police tactics, I don’t think that would be a ‘loss’ for the cops. It’s probably best to see their strategy as one of kicking the ball forward as far as they can in terms of the tactics they can get away with. Public outrage and judicial action may subsequently kick the ball back a certain distance, but as long as it ends up further than it was before last weekend, that is a police victory of sorts. So in general I am pessimistic about how much good can come directly out of all this. Indirectly, though, I think there is reason to hope that this outrage is bringing more people together, and building awareness of the fundamental injustice which underpins our society, which cannot be confronted until it is exposed, and which is now harder to ignore when over 1000 peaceful protesters and bystanders have been arbitrarily beaten, jailed, or both..